Sacral neuromodulation therapy for urinary and defecatory disorders: experience in a Latin American public hospital

Abstract Objective: To show the experience of a Latin American public hospital, with SNM in the management of either OAB, NOUR or FI, reporting feasibility, short to medium-term success rates, and complications. Methods: A retrospective cohort was conducted using data collected prospectively from patients with urogynecological conditions and referred from colorectal surgery and urology services between 2015 and 2022. Results: Advanced or basic trial phases were performed on 35 patients, 33 (94%) of which were successful and opted to move on Implantable Pulse Generator (GG) implantation. The average follow-up time after definitive implantation was 82 months (SD 59). Of the 33 patients undergoing, 27 (81%)reported an improvement of 50% or more in their symptoms at last follow-up. Moreover, 30 patients (90%) with a definitive implant reported subjective improvement, with an average PGI-I "much better" and 9 of them reporting to be "excellent" on PGI-I. Conclusion: SNM is a feasible and effective treatment for pelvic floor dysfunction. Its implementation requires highly trained groups and innovative leadership. At a nation-wide level, greater diffusion of this therapy among professionals is needed to achieve timely referral of patients who require it.

Manejo exitoso de síndrome de vejiga hiperactiva refractaria con toxina botulínica A / Successful management of refractory overactive bladder syndrome with botulinum toxin A

Introducción: El síndrome de vejiga hiperactiva (VHA) afecta hasta al 43% de las mujeres. La terapia escalonada incluye cambios de hábitos, fármacos y neuromodulación. Hasta el 40% de las pacientes llegan a requerir terapia avanzada alternativa, como toxina botulínica (TB). Objetivo: Reportar los resultados del tratamiento con toxina botulínica en mujeres con VHA refractaria a tratamiento de primera y segunda línea, en un hospital público en Chile. Método: Estudio de cohorte retrospectivo desde una base de datos recolectada prospectivamente del Hospital Sótero del Río entre 2018 y 2022. Se incluyeron 33 pacientes con tratamiento farmacológico y neuromodulación previa, con una edad promedio de 57 años, sometidas a inyección cistoscópica de TB a detrusor, analizando datos demográficos, antecedentes y complicaciones. Se realizó seguimiento con frecuencia miccional, paños/día, escala de gravedad de Sandvik (ISI) y encuesta Patient Global Impression Improvement (PGI-I). Resultados: Los datos comparativos pre/post TB, respectivamente, fueron: frecuencia miccional diurna 11/6 y nocturna 5/1; paños/día 5/3; ISI 8/3. Veinte de 33 mujeres refirieron estar excelente o mucho mejor (PGI-I). Conclusiones: Es posible realizar manejo con TB en mujeres con VHA refractaria a primera y segunda línea, con buenos resultados e impacto significativo en la calidad de vida.

Introduction: Overactive bladder syndrome (OABS) affects up to 43% of women. Staggered therapy includes habit changes, drugs, and peripheral neuromodulation. Up to 40% of patients may require advanced alternative therapy such as botulinum toxin A (BT). Objective: To report the results of treatment with TB in women with OABS refractory to first- and second-line treatment in a public hospital in Chile. Method: Retrospective cohort study from prospectively collected database from Hospital Sótero del Río between 2018 and 2022. Thirty-three patients with previous pharmacological treatment and neuromodulation were included, with an average age of 57 years, undergoing cystoscopic injection of TB to detrusor. Demographic data, history, and complications were analyzed. Follow-up was performed with voiding frequency, cloths/day, Sandvik Severity Scale (ISI) and Patient Global Impression Improvement (PGI-I) survey. Results: Comparative data pre/post TB, respectively showed: daytime voiding frequency 11/6 and nighttime 5/1; cloths/day 5/3; ISI 8/3. 20 of 33 women reported being excellent or much better (PGI-I). Conclusions: TB management in women with OABS refractory to first- and second-line treatment has good results and significant impact on quality of life.

Mirabegron and Anticholinergics in the Treatment of Overactive Bladder Syndrome: A Meta-analysis / Mirabegron e anticolinérgicos no tratamento da síndrome da bexiga hiperativa: metanálise

Abstract Objective To compare the use of mirabegron with anticholinergics drugs for the treatment of overactive bladder (OB). Data Source Systematic searches were conducted in EMBASE, PUBMED, Cochrane, and LILACS databases from inception to September 2021. We included RCTs, women with clinically proven OB symptoms, studies that compared mirabegron to antimuscarinic drugs, and that evaluated the efficacy, safety or adherence. Data Collection RevMan 5.4 was used to combine results across studies. We derived risk ratios (RRs) and mean differences with 95% CIs using a random-effects meta-analytic model. Cochrane Collaboration Tool and GRADE was applied for risk of bias and quality of the evidence. Data Synthesis We included 14 studies with a total of 10,774 patients. Fewer total adverse events was reported in mirabegron group than in antimuscarinics group [RR 0.93 (0.89-0.98)]. The risk of gastrointestinal tract disorders and dry mouth were lower with mirabegron [RR 0,58 (0.48-0.68); 9375 patients; RR 0.44 (0.35-0.56), 9375 patients, respectively]. No difference was reported between mirabegron and antimuscarinics drugs for efficacy. The adherence to treatment was 87.7% in both groups [RR 0.99 (0.98-1.00)]. Conclusion Mirabegron and antimuscarinics have comparable efficacy and adherence rates; however, mirabegron showed fewer total and isolated adverse events.

Resumo Objetivo Comparar o uso de mirabegrom com anticolinérgicos para o tratamento da bexiga hiperativa (BH). Fonte de Dados Buscas sistemáticas foram realizadas nas bases de dados EMBASE, PUBMED, Cochrane e LILACS desde o início até setembro de 2021. Incluímos ECR, mulheres com sintomas de BH clinicamente comprovados, estudos que compararam mirabegrom a medicamentos antimuscarínicos e avaliaram a eficácia, segurança ou adesão. Coleta de Dados RevMan 5.4 foi usado para combinar os resultados entre os estudos. Derivamos razões de risco (RRs) e diferenças médias com intervalo de confiança (IC) de 95% usando um modelo meta-analítico de efeitos aleatórios. Cochrane Collaboration Tool e GRADE foi aplicado para risco de viés e qualidade da evidência. Síntese dos Dados Foram incluídos 14 estudos com um total de 10.774 pacientes. Menos eventos adversos totais foram relatados no grupo mirabegrom do que no grupo antimuscarínicos [RR: 0,93 (0,89-0,98)]. O risco de distúrbios do trato gastrointestinal e boca seca foram menores com mirabegrom [RR: 0,58 (0,48-0,68); 9.375 pacientes; RR: 0,44 (0,35-0,56), 9.375 pacientes, respectivamente]. Nenhuma diferença foi relatada entre mirabegrom e drogas antimuscarínicos para eficácia. A adesão ao tratamento foi de 87,7% em ambos os grupos [RR: 0,99 (0,98-1,00)]. Conclusão Mirabegrom e antimuscarínicos têm eficácia e taxas de adesão comparáveis, porém o mirabegrom apresentou menos eventos adversos totais e isolados.

Use of Urodynamics by Gynecologists and Urologists in Brazil / Uso da urodinâmica por ginecologistas e urologistas no Brasil

Abstract Objective Urodynamic studies (UDSs) are a set of tests that assess the storage and emptying of urine, and they are widely used by gynecologists and urologists in the management of urinary incontinence (UI), despite the discussion about its indications. The objectives of the present study were to verify whether UDSs are routinely used in the conservative and surgical approaches to female UI, their other clinical indications, and to compare the responses of Brazilian gynecologists and urologists. Methods The present is an opinion survey applied from August 2020 to January 2021 through a semistructured questionnaire about the clinical practice sent by e-mail to all participants. The responses were compared through statistical analyses. Results Of the 329 participants, 238 were gynecologists (72.3%) and 91, urologists (27.7%). Most gynecologists (73.5%) and urologists (86.6%) do not request UDSs before the conservative treatment of UI; but UDSs are indicated in the preoperative period of anti-incontinence surgeries. Most participants request UDSs in the initial approach to overactive bladder (gynecologists: 88.2%; urologists: 96.7%), and the urologist has greater chance to request this study (odds ratio [OR] = 3.9). For most participants, it is necessary to request uroculture before the UDSs. Conclusion Most Brazilian gynecologists and urologists who participated in the present study do not request UDSs before the conservative treatment of UI, according to national and internacional guidelines, and often request it before the surgical treatment for female UI. The indication of this exam in the initial approach of idiopathic overactive bladder should be reviewed by the participants.

Resumo Objetivo O estudo urodinâmico (EU) é um conjunto de exames que avalia o armazenamento e esvaziamento da urina, e é amplamente utilizado por ginecologistas e urologistas no manejo da incontinência urinária (IU), apesar das discussões sobre suas indicações. O objetivo deste estudo foi verificar se a urodinâmica é rotineiramente utilizada nas abordagens conservadora e cirúrgica da IU feminina, além de outras de suas indicações clínicas, e comparar as respostas de ginecologistas e urologistas brasileiros. Métodos Trata-se de uma pesquisa de opinião, realizada entre agosto de 2020 e janeiro de 2021, por meio de questionário semiestruturado composto por perguntas sobre a prática clínica enviado por e-mail a todos os participantes. As respostas foram comparadas mediante análises estatísticas. Resultados Dos 329 participantes, 238 eram ginecologistas (72,3%) e 91, urologistas (27,7%). A maioria dos ginecologistas (73,5%) e urologistas (86,6%) não solicita EU antes do tratamento conservador da IU; mas o EU é indicado no pré-operatório de cirurgias para IU. A maioria dos participantes solicita EU na abordagem inicial da bexiga hiperativa (ginecologistas: 88,2%; urologistas: 96,7%), e os urologistas têm maior chance de solicitar esse exame (razão de chances [RC] = 3,9). Para a maioria dos entrevistados, é necessário solicitar urocultura junto com o EU. Conclusão A maioria dos ginecologistas e urologistas brasileiros que participaram deste estudo não solicita EU antes do tratamento conservador da IU, de acordo com as principais diretrizes nacionais e internacionais, e muitas vezes o solicita antes do tratamento cirúrgico da IU feminina. A indicação desse exame na abordagem inicial da bexiga hiperativa idiopática deve ser revista pelos participantes.

The effect of vitamin D deficiency in children with overactive bladder related urinary incontinence

ABSTRACT Purpose: Overactive bladder (OAB) is a common syndrome associated with lower urinary tract symptoms (LUTS), especially urinary incontinence in children, which may affect the patient's quality of life (QoL). Vitamin D deficiency has been shown to be associated with OAB syndrome. This study evaluated the relationship between vitamin D status and OAB-related symptoms and QoL in children. Materials and Methods: The study included 52 pediatric patients with OAB-related urinary incontinence and 41 healthy children. LUTS were assessed using the Dysfunctional Voiding and Incontinence Symptoms Score (DVISS) questionnaire, and QoL was assessed using the Pediatric Incontinence Questionnaire (PINQ). Oral vitamin D supplementation was given to patients with OAB with vitamin D deficiency. Urinary symptoms and QoL were evaluated before and after vitamin D supplementation. Results: Vitamin D deficiency was more common in the OAB group (75%) than in the control group (36.6%). Logistic regression analysis revealed that vitamin D status (<20ng/mL) was a significant predictor of OAB. Both pre-treatment and post-treatment DVISS and PINQ scores showed a positive correlation. After vitamin D supplementation, 8 (23.5%) patients had a complete response and 19 (55.9%) patients had a partial response. Significant improvement in QoL was also achieved. Conclusions: Vitamin D deficiency is more common in children with urinary incontinence and OAB than in healthy children. Although vitamin D deficiency is not routinely evaluated for every patient, it should be evaluated in treatment-resistant OAB cases. Vitamin D supplementation may improve urinary symptoms and QoL in patients with OAB.

Uso do estudo urodinâmico por ginecologistas e urologistas no Brasil / Use of the urodynamic study by gynecologists and urologists in Brazil

Objetivo: O estudo urodinâmico (EUD) é um conjunto de exames que estuda o armazenamento e o esvaziamento da urina e é amplamente utilizado por ginecologistas e urologistas na abordagem da incontinência urinária (IU) feminina, apesar da discussão sobre suas indicações. Os objetivos do estudo foram verificar se a urodinâmica é utilizada rotineiramente na abordagem conservadora e cirúrgica da IU feminina, e quais outras indicações clínicas, comparando as respostas entre ginecologistas e urologistas brasileiros. Métodos: Trata-se de uma pesquisa de opinião por meio de um questionário semiestruturado, composto por perguntas sobre a prática clínica em IU, enviado por e-mail a ginecologistas e urologistas, e realizada entre agosto de 2020 e janeiro de 2021. As respostas foram comparadas por meio de análises estatísticas. Resultados: Dos 329 participantes, 238 (72,3%) eram ginecologistas e 91 (27,7%), urologistas. A maioria dos ginecologistas (73,5%) e urologistas (86,6%) não solicita EUD antes do tratamento conservador da IU, mas o EUD é indicado rotineiramente no pré-operatório de cirurgias anti-incontinência. A maioria dos participantes indica EUD na abordagem inicial da bexiga hiperativa (88,2% vs. 96,7%) e há maior chance de o urologista solicitar mais EUD nessa situação (OR = 3,9). Para a maioria dos participantes, é necessário solicitar a urocultura antes do EUD. Conclusão: A maioria dos ginecologistas e urologistas brasileiros não solicita o EUD antes do tratamento conservador da IU, de acordo com as diretrizes nacionais e internacionais, e muitas vezes solicita antes do tratamento cirúrgico da IU feminina. A indicação desse exame na abordagem inicial da bexiga hiperativa idiopática deve ser revisada pelos participantes.(AU)

Experiencia con el uso de toxina botulínica en niños con vejiga hiperactiva neurogénica: Una serie de casos / Experience with Botulinum Toxin in Children with Neurogenic Overactive Bladder: A Case Series

Objetivo Describir la experiencia con la administración de inyección de toxina botulínica en niños con vejiga hiperactiva neurogénica refractaria a manejo de primera línea. Materiales y Métodos Estudio observacional descriptivo (serie de casos) que incluyó a 14 niños con diagnóstico de vejiga hiperactiva neurogénica refractarios a tratamiento de primera línea sometidos a administración intravesical de toxina botulínica entre 2015 y 2021; se realizó el seguimiento teniendo en cuenta las variables clínicas, con evaluación de la respuesta y de los eventos adversos. Se reportaron frecuencias absolutas y porcentajes para las variables cualitativas; para las variables cuantitativas, se reportaron medidas de tendencia central y dispersión. Resultados Se incluyeron 6 niños y 8 niñas, con una media de edad 10,1 (desviación estándar [DE]: ± 4,4) años. Todos los pacientes fueron tratados previamente con anticolinérgico y cateterismos limpios intermitentes, con una media de uso de 2,8 (DE: ± 1.0) pañales al día; 11 (78,5%) pacientes tenían antecedente de infección urinaria, 13 (92,8%), estreñimiento, y 2 (15,3%), incontinencia fecal. En la ecografía, 7 (50,0%) pacientes presentaban engrosamiento de las paredes vesicales, y 6 (42,8%), hidronefrosis. Tras el procedimiento, 1 paciente presentó infección urinaria como complicación, 6 presentaron una respuesta completa, 7, respuesta parcial, y 1 paciente no obtuvo respuesta con la primera inyección, con un tiempo promedio efectivo de la terapia 8 (DE: ± 6,3) meses. Una segunda inyección fue necesaria en 6 (42.8%) pacientes, y, de estos, 3 (50%) requirieron una tercera inyección. Conclusión La inyección de toxina botulinica intravesical como terapia de segunda línea de manejo para vejiga hiperactiva neurogénica tiene buenos resultados, con bajas tasas de complicaciones.

Objective To describe the experience with the administration of botulinum toxin injection in children with neurogenic overactive bladder who were refractory to the first-line management. Materials and Methods A descriptive observational study (case series) which included 14 children with a diagnosis of neurogenic overactive bladder who were refractory to the first-line treatment and were aubmitted to the intravesical administration of botulinum toxin between 2015 and 2021. Follow-up was performed taking into account the clinical variables, wth an evaluation of the response and the adverse events. Absolute frequencies and percentages were reported for the qualitative variables; for the quantitative variables, measures of central tendency and dispersion were reported. Results We included 6 boys and 8 girls with a mean age of 10.1 (standard deviation [SD]: ± 4.4) years. All patients were previously treated with anticholinergics and clean intermittent catheterizations, with a mean use of 2.8 (SD: ± 1.0) diapers per day; 11 (78.5%) had a history of urinary tract infection, 13 (92.8%), constipation, and 2 (15.3%), fecal incontinence. On ultrasound, 7 (50.0%) patients presented bladder wall thickening, and 6 (42.8%), hydronephrosis. After the procedure, 1 patient presented urinary tract infection as a complication, 6 presented complete response, 7, partial response, and 1 patient did not obtain a response with the first injection, with an effective mean time of therapy of 8 (SD: ± 6.3) months. A second injection was required by 6 (42.8%) patients, and of these, 3 (50%) required a third injection. Conclusion Intravesical botulinum toxin injection as a second-line management therapy for neurogenic overactive bladder yileds good results, with low rates of complications.

Efficacy of intravaginal electrical stimulation added to bladder training in women with idiopathic overactive bladder: A prospective randomized controlled trial

ABSTRACT Purpose: To evaluate the efficacy of intravaginal electrical stimulation (IVES) added to bladder training (BT) on incontinence-related quality of life (QoL) and clinical parameters in women with idiopathic overactive bladder (OAB). Materials and Methods: Sixty-two women with idiopathic OAB were randomized into two groups using the random numbers generator as follows: Group 1 received BT alone (n:31), and Group 2 received BT+IVES (n:31). IVES was performed for twenty minutes three days a week over a course of eight weeks for a total of 24 sessions. Patients were evaluated in terms of incontinence severity (24-hour pad test), pelvic floor muscles strength (perineometer), 3-day voiding diary (frequency of voiding, nocturia, incontinence episodes and number of pads), symptom severity (OAB-V8), incontinence-related QoL (IIQ-7), treatment success (positive response rate), cure/improvement rate and treatment satisfaction (Likert scale). Results: A statistically significant improvement was found in all parameters for all groups at the end of the treatment compared to the baseline values except pelvic floor muscles strength in Group 1 (p <0.05). At the end of treatment, incontinence severity, frequency of voiding, nocturia, incontinence episodes, number of pads, symptom severity, and QoL were significantly improved in Group 2 compared to Group 1 (p <0.05). Treatment satisfaction, cure/improvement, and positive response rates were significantly higher in group 2 compared to Group 1 (p <0.05). Conclusion: We conclude that BT+IVES were more effective than BT alone on both incontinence-related QoL and clinical parameters in women with idiopathic OAB.

Current pharmacotherapy of overactive bladder

ABSTRACT Overactive bladder is a symptom complex consisting of bothersome storage urinary symptoms that is highly prevalent among both sexes and has a significant impact on quality of life. Various antimuscarinic agents and the beta-3 agonists mirabegron and vibegron are currently available for the treatment of OAB. Each drug has specific pharmacologic properties, dosing schedule and tolerability profile, making it essential to individualize the medical treatment for the patient's characteristics and expectations. In this manuscript, we review the most important factors involved in the contemporary pharmacological treatment of OAB.

Evaluation of autonomic function in children and adolescents with overactive bladder

ABSTRACT Aims: To evaluate autonomic activity in children/adolescents with isolated overactive bladder. Materials and Methods: Descriptive, analytical, non-interventional, cross-sectional study conducted between February 2017 and January 2018 with individuals aged between 5 and 17 years old, with overactive bladder (OAB group) or asymptomatic (control). Neurological or anatomical abnormalities, diabetes mellitus and kidney failure constituted exclusion criteria. The DVSS and the Rome III questionnaire were applied, and heart rate variability (HRV) was assessed. The chi-square test, Student's t-test, ANOVA and the Mann Whitney U test were used in the statistical analysis. Results: 41 patients with OAB and 20 controls were included. In the OAB group, there were more girls (p=0.23), more overweight/obese and constipated patients. The DVSS score was higher in the OAB group. HRV showed a higher heart rate variability at the frequency domain and LF/HF variation in the control group (p=0.02 and p=0.05 respectively). In the intergroup evaluation, LF (Hz) was predominant in the control group at the post-voiding evaluation moment (p=0.03). Conclusion: The control group demonstrated a physiological heart rate variation during the voiding process, with a predominance of sympathetic activity during urinary storage.

Costoefectividad del régimen combinado de mirabegron/solifenacina en el tratamiento del síndrome de vejiga hiperactiva en Colombia / Cost-effectiveness of the Combined Regimen of Mirabegron/Solifenacin in the Treatment of Overactive Bladder Syndrome in Colombia

Objetivo Evaluar la costoefectividad incremental del régimen combinado de mirabegron/solifenacina en comparación con el uso temprano de toxina botulínica, desde la perspectiva del sistema de salud colombiano, para el tratamiento de adultos con vejiga hiperactiva. Métodos Se empleó un modelo de Markov en que se comparan dos secuencias de tratamiento, una con y otra sin mirabegron/solifenacina, para evaluar la costoefectividad en un horizonte temporal de cinco años. Debido a la perspectiva de análisis, sólo se tuvieron en cuenta los costos médicos directos. La eficacia del tratamiento evaluado y su comparador fue medida en términos de la reducción de episodios diarios de incontinencia y de la frecuencia de micciones. Los costos fueron expresados en pesos colombianos de 2019, y se aplicó una tasa de descuento de 5% tanto para desenlaces como para costos. Resultados Para el caso base, el costo del tratamiento en la secuencia que incluye mirabegron/solifenacina fue mayor, pero generó un mayor número de años de vida ajustados por calidad, y así e obtuvo una razón de costoefectividad incremental de $13.637,184 si se considera el desenlace de reducción de episodios diarios de incontinencia de 50%, y de $29.313,848 si se considera el del 100%. Conclusiones De acuerdo con los resultados de esta evaluación, para un horizonte de análisis de cinco años, la secuencia de tratamiento con mirabegron/solifenacina es una alternativa costoefectiva, si se considera un umbral de disposición a pagar de tres veces el producto interno bruto (PIB) per cápita.

Aim To evaluate the incremental cost-effectiveness of the combined regimen of mirabegron/solifenacin compared with the early use of botulinum toxin, from the perspective of the Colombian health system, for the treatment of adults with overactive bladder. Methods A Markov model comparing two treatment sequences, one with and one without mirabegron/solifenacin, was used to assess cost-effectiveness over a five-year period. Due to the perspective of the analysis, only direct medical costs were considered. The efficacy of the evaluated treatment and its comparator was measured in terms of the reduction in the daily incontinence episodes and the frequency of micturition. The costs were expressed in Colombian pesos of 2019, and a discount rate of 5% was applied for both outcomes and costs. Results For the base case, the cost of the treatment in the sequence that includes mirabegron/solifenacin was higher, but it generated a greater number of quality-adjusted years of life, thus obtaining an incremental cost-effectiveness ratio of $13,637,184 when considering the outcome of 50% of reduction in the daily incontinence episodes, and $29,313,848 when considering 100%. Conclusions According to the results of the present assessment, for a five-year period of analysi, the mirabegron/solifenacin treatment sequence is a cost-effective alternative when considering a threshold of willingness to pay three times the per capita gross domestic product (GDP).

Parasacral transcutaneous electrical nerve stimulation in children with overactive bladder: comparison between sessions administered two and three times weekly

ABSTRACT Purpose: This study compares the results achieved following parasacral TENS administered using two different weekly schedules. Materials and Methods: Children of at least four years of age with a diagnosis of pure overactive bladder were included in this randomized clinical trial and treated with parasacral TENS (2 versus 3 sessions per week). All the participants also underwent standard urotherapy. Results: Sixteen children were included in the twice-weekly group and eighteen in the three times weekly group. There were no statistically significant differences between the two groups with respect to sex; however, there was a difference in age. There were no significant differences regarding complete resolution of urinary symptoms, with 8 children (50%) in the twice-weekly group and 11 children (61%) in the three times weekly group having their symptoms completely resolved (p=0.73). There was a significant difference in the DVSS score in both groups following TENS treatment compared to baseline (p=0.0001 for both groups), but not between groups. Evaluation of the bladder diary showed no difference between the groups before or after treatment. Conclusion: For children with overactive bladder who are unable to undergo parasacral TENS treatment three times weekly, the method can be administered successfully at twice-weekly sessions.